Research Triangle Park, North Carolina, May 13, 2014 — Marken announced today that it has been granted approval for a customs-bonded warehouse within the Marken Clinical Supply Center in Frankfurt, Germany. This will allow Marken to store pharmaceuticals with an origin outside the European Union (EU) and distribute them to non-EU countries without undergoing the EU importation procedure for pharmaceuticals.
Importation of pharmaceuticals into the EU requires that each batch arriving must be certified by the Qualified Person (QP) of the company holding the import license. This procedure requires detailed knowledge of the pharmaceutical company’s manufacturing process and all supporting documentation. A customs-bonded warehouse is then able to store clinical supplies that come from outside the EU and ship them directly to non-EU countries without sending them through the lengthy EU importation and QP release process.
Andrea Zobel, Marken’s Vice President of Global Project Management & Feasibility explained the client benefits of a customs-bonded warehouse, “With this certification, pharmaceuticals sent through a customs warehouse can now be shipped to non-EU countries as soon as the clinical trial is approved. This will obviously speed up delivery to the patients and investigator sites who are awaiting these clinical trial materials.”
Marken’s customs warehouse will allow optimization of the distribution process, shorten timelines for imports and supplies, and allow its QPs to dedicate all of their time to required regulatory tasks. The Marken Frankfurt location is an ideal location for this service given that it is central to all time zones and provides fast connections to many countries.
Additional information on the benefits of a customs warehouse in the EU is available in Marken’s white paper: Utilization of Customs Warehouses in the Clinical Trial Supply Chain, which can be downloaded at www.marken.com.